OpenLobby.EU
Explore

Targeted revision of the EU rules for medical devices and in vitro diagnostics

Public health

This initiative seeks to simplify EU rules for medical devices and in vitro diagnostics. Its main goal is to ensure availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare. The initiative seeks to strengthen the competitiveness of the EU medical device sector in the internal market and globally to support innovation and reduce dependencies. The initiative relies on an evaluation of the current regulations and aims to make the safety requirements more cost-efficient and proportionate.

Links

Public consultation

ID: 14808

Lobbying Activity

79 responses

Danish industry urges faster, cheaper EU medical device certification

BUSINESSEUROPE, 6 Oct 2025

The industry calls for faster, more predictable certification processes that reduce costs for companies. They propose creating fast-track procedures for innovations and removing mandatory five-year recertification requirements.
Streamlined regulations would lower administrative burdens and protect the sector's global market position.

EFPIA urges streamlined EU device rules to end clinical trial delays

European Federation of Pharmaceutical Industries and Associations, 6 Oct 2025

EFPIA requests establishing a single EU accountable body for harmonised oversight, implementing an All-in-One coordination process for combined trials, introducing risk-based evaluation frameworks, and extending exemptions for in-house testing in central laboratories. They seek accelerated pathways for emergency use and early access to companion diagnostics.
This would reduce trial delays affecting up to 42,200 patients and accelerate launch of up to 89 therapies.

German industry chamber urges medical device regulation simplification

Deutsche Industrie- und Handelskammer, 26 Sept 2025

The DIHK requests cutting bureaucracy by ending the mandatory five-year recertification cycle. They also propose merging artificial intelligence rules into the medical device regulations.
Manufacturers would benefit from lower compliance costs and improved planning security for innovations.
Notified bodies would lose revenue if annual certificate fees and recertification requirements are removed.

MedTech Europe urges streamlined EU medical device regulations

MedTech Europe, 6 Oct 2025

The organization requests a single governance structure, risk-based conformity assessment, and removal of duplicative requirements. They advocate for simplified pathways for low-risk devices and accelerated approval for breakthrough innovations. They also seek unlimited certification validity and broader use of real-world data for clinical evidence.
This would reduce lifecycle costs and provide greater planning certainty for investment.

Irish Medtech urges EU to prioritise efficiency and innovation in device regulation reform

Ibec, 6 Oct 2025

The organization requests swift implementation of short-term relief measures including defined timelines for product review, reduced re-certification burden, and fast-track pathways for breakthrough innovation. They recommend reform of the Notified Body approval process, greater efficiencies through digitalization and AI, and establishment of a single governance structure to oversee the system.
This would reduce unpredictable review times and excessive certification costs for startups and SMEs.
European patients lose timely access to innovative medical technologies that launch first in other markets.

EuropaBio urges streamlined rules for combined drug-device clinical trials

EuropaBio, 6 Oct 2025

EuropaBio calls for a harmonised procedure for combined drug-device trials to replace repetitive applications. They advocate for parallel assessments, standardized timelines, and specific exemptions for rare disease diagnostics.
Streamlined procedures would reduce the regulatory burden and accelerate biotech innovation timelines.
Patients face delayed access to innovative treatments due to inefficient regulatory procedures.

Consultation response

APPLiA (Home Appliance Europe), 6 Oct 2025

APPLiA represents hosehold appliances manufacturers in Europe. More info about us can be found at www.applia-europe.eu. We would like to respond to the Medical devices and in vitro diagnostics targeted revision of EU rules call for evidence with follwoing comments/questions. In general there is a…

European Patients' Forum urges stronger safety oversight and patient information in device regulations

European Patients' Forum (EPF), 6 Oct 2025

The organization requests binding guidance for safety investigations with strict deadlines, mandatory post-market data collection for breakthrough devices, and expanded EUDAMED information including recalls and complications. They demand patient involvement in governance through a permanent forum.
This would give patients faster access to safety information and ensure their voices shape device regulation.

Philips Calls for Centralized Governance to Fix EU Medical Device Rules

Koninklijke Philips, 6 Oct 2025

Philips wants a centralized governance structure to harmonize certification procedures across notified bodies, with fixed prices and binding timelines. They seek abolishment of routine recertification and better alignment with international standards like IMDRF and MDSAP.
This would reduce certification delays and costs from unpredictable notified body processes.

European pharma entrepreneurs demand medical device regulation reform

European Confederation of Pharmaceutical Entrepreneurs, 6 Oct 2025

The organization requests harmonized timelines for clinical trial reviews, standardized documentation procedures, and clarification of rules for device-drug combinations. They argue current processes are complex, inconsistent, and delay studies by 6-12 months.
This would reduce approval delays and enable faster clinical research in Europe.

ESC urges centralized agency to solve EU medical device shortages

European Society of Cardiology, 6 Oct 2025

The ESC calls for a single EU agency to coordinate regulatory assessments and clinical evidence. They recommend creating priority pathways for breakthrough technologies and involving healthcare professionals throughout the process.
Centralization would improve cardiac patient care by ensuring a steady supply of equipment.
National agencies lose power as regulatory authority shifts to a single coordinating pinpoint.

Detergents industry seeks 10-year extension for medical device compliance

Association Internationale de la Savonnerie, de la Détergence et des Produits d'Entretien, 3 Oct 2025

The organization requests extending the transition period until 2031/2032, eliminating clinical evaluation requirements for products with indirect clinical benefit like disinfectants, and extending certificate validity to 10 years. They argue MDR documentation requirements are far more demanding than previous rules.
This would reduce costly re-certifications and extensive documentation burdens for their cleaning products.

Self-care industry urges simplification of medical device regulations

Association of the European Self-Care Industry, 6 Oct 2025

The organization requests targeted reforms to simplify classification rules, reduce administrative burdens including reporting obligations, and enable digitalization. They emphasize reforms must maintain high standards for patient safety.
This would reduce compliance costs reaching millions per company portfolio.

Medical imaging industry urges structural reform of EU device regulations

European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, 3 Oct 2025

COCIR requests eliminating the five-year recertification requirement, establishing centralized governance for medical devices, and introducing structured pre-submission dialogues with notified bodies. They seek simplified clinical validation requirements and dedicated pathways for innovative technologies addressing unmet clinical needs.
This would reduce recertification costs and speed up market access for medical imaging devices.

European Doctors Urge EMA Leadership to Protect Medical Device Safety

Standing Committee of European Doctors, 9 Sept 2025

CPME supports centralizing oversight under the EMA and requiring manufacturers to disclose clinical effectiveness data. Digital labels should not replace paper versions. They reject automatic device approvals if regulatory deadlines are missed.
Consistent data access allows doctors to provide safer treatments and better clinical guidance.
Manufacturers lose the possibility of automatic market access when certification bodies face delays.

Siemens Healthineers urges shift to surveillance-based device certification

Siemens Healthineers AG, 6 Oct 2025

Siemens Healthineers proposes replacing fixed-term recertifications with a surveillance-based approach to maintain certificate validity. They also want purely administrative changes excluded from full certification to reduce unnecessary market delays.
Reducing recertification requirements would significantly lower administrative costs and expedite market entry.
Patient safety advocates may lose the rigorous oversight provided by mandatory five-year device recertifications.

European Brain Council urges faster medical device approval reforms

European Brain Council, 6 Oct 2025

The council requests harmonized evaluation criteria and binding review timelines. They also seek increased capacity at Notified Bodies and better transparency during certification.
Reform would provide neurosurgical patients faster access to treatments that improve survival.
Large non-European companies would lose the market advantage created by high compliance costs.

German social insurance backs medical device reform while safeguarding safety

Deutsche Sozialversicherung Europavertretung, 2 Oct 2025

The DSV supports reducing bureaucracy and digitizing documentation procedures. They want legally enshrined definitions for orphan medical devices. They also propose establishing Europe-wide registries for clinical data.
This ensures a stable supply of medical devices for their insured members.
Manufacturers of rare disease devices face more burdensome and mandatory data collection.

IDF Europe demands stricter safety oversight for medical devices

International Diabetes Federation European Region, 6 Oct 2025

The organization recommends strengthening oversight by expanding the EMA's role in evaluating clinical evidence. They also propose an Innovation Pathway to speed up the approval of breakthrough technologies. Finally, they call for mandatory disclosure of performance data to increase transparency.
Enhanced transparency and faster innovation would improve treatment outcomes and safety for patients.
Medical device manufacturers could face higher compliance costs and competitive risks from transparency.

GIRP urges EU to simplify medical device sampling rules

European Healthcare Distribution Association, 6 Oct 2025

The association requests a risk-based approach that limits sampling to cases where reasonable suspicion occurs. They also call for harmonized risk classifications to resolve conflicting tracking obligations for medical devices across Member States.
This would reduce operational costs and prevent the unnecessary destruction of products.
National regulators would lose the authority to perform routine, non-suspicion-based safety inspections.

Leaseurope urges EU to exempt finance lessors from device rules

Leaseurope, 1 Oct 2025

Leaseurope requests a legal clarification to ensure that financial entities are not classified as distributors. They suggest adding a new recital to better define market availability for assets.
This change prevents increased compliance costs and avoids technical liability for finance firms.
Reduced financing options could hinder access to essential equipment for SMEs and hospitals.

ESIP urges safety safeguards in medical device rule revision

European Social Insurance Platform AISBL, 6 Oct 2025

ESIP supports reducing administrative burdens but insists that patient safety and clinical data quality must remain a priority. They call for a dedicated legal framework for orphan and breakthrough devices to improve market access. Revisions should focus on eliminating redundant documentation through digitalization.
High-quality clinical data enables more precise reimbursement decisions for social insurers.
Manufacturers would face increased burdens from mandatory registries and post-market data collection.

BEAM Alliance demands IVDR reforms to support AMR diagnostics

BEAM Alliance, 6 Oct 2025

The group requests streamlining requirements to reduce regulatory costs and delays for innovative products. They advocate for a central expert group and more professionalised Notified Bodies with standardised costs.
Reducing compliance burdens would make these SMEs more attractive to investors.
Notified Bodies would lose pricing autonomy and confidentiality of their internal processes.

Italian chemical industry seeks simpler medical gas rules

Federazione Nazionale dell'Industria Chimica italiana, 1 Oct 2025

The association requests uniform classification across Europe and simplified rules for well-established technologies. They argue that complex design procedures and clinical evaluations are not necessary for these devices. Finally, they suggest reducing audit frequency and certification costs.
This would significantly lower administrative burdens and costs for medical gas producers.
Notified Bodies would face reduced income due to lower audit frequencies and simplified processes.

Edwards Lifesciences Urges Fast-Track Path for Breakthrough Innovations

Edwards Lifesciences, 6 Oct 2025

The company proposes an EU designation and a 120-day priority review for breakthrough technologies. They also advocate for conditional marking to accelerate access to innovative implantable devices.
Faster approvals would help the company maintain its competitive edge and reduce costs.
Transparency groups could lose access to data if reporting obligations are removed.

ESMO warns EU diagnostic rules threaten vital cancer research

European Society for Medical Oncology (ESMO), 6 Oct 2025

ESMO requests a mandatory, single-entry application system to reduce regulatory fragmentation across Member States. They also seek exemptions for lower-risk trials and a formalised scientific advice process.
Streamlining rules helps maintain Europe’s research base and prevents clinical trial relocation.
European patients face delayed access to innovative and life-saving cancer treatments.

Cancer Patients Europe urges faster approvals for life-saving devices

Cancer Patients Europe, 6 Oct 2025

The group calls for cutting administrative red tape and duplicative steps to speed up device approvals. They also demand that patient organizations be formally included in regulatory governance and shortage planning.
Patients would secure more reliable access to essential cancer treatments and diagnostic tools across Europe.

German doctors warn against permanent medical device certificates

Bundesärztekammer, 6 Oct 2025

The organization supports simplifying recertification while requiring mandatory reviews every five years. They oppose permanent certificates and want innovation incentives based on objective criteria.
Maintaining strict standards ensures that medical professionals can rely on device safety.
Manufacturers lose the chance to avoid costs associated with regular regulatory re-evaluations.

Roche urges faster, synchronized EU medical device regulatory reforms

F. Hoffmann-La Roche Ltd, 6 Oct 2025

Roche requests synchronized decision-making to prevent 'ready' products from being held in regulatory patterns. They advocate for simplified clinical study pathways by removing redundant national requirements.
Roche would benefit from reduced complexity and faster timelines for new products.
National governments lose the ability to maintain their own specific authorization requirements.

Amgen Urges Faster Approvals for Drug-Device Combination Products

Amgen Inc, 3 Oct 2025

Amgen proposes aligning regulations for different types of combination products under a single lead authority. They suggest synchronizing device reviews with medicine applications to ensure faster market entry. Finally, they recommend eliminating duplicate inspections through a formal reliance framework.
This would significantly reduce product launch delays and administrative costs for companies.

Consultation response

Zimmer Biomet Holdings, 6 Oct 2025

Zimmer Biomet, a global leader in medical technology, has always supported the good intentions of all parties to implement the EU Regulation 2017/745 on medical devices (MDR) as smoothly as possible within the defined transition period. However, despite extensive efforts, the system is not…

Consultation response

Deutsche Krankenhausgesellschaft e.V., 1 Oct 2025

Als Dachorganisation der deutschen Krankenhäuser in öffentlicher, freigemeinnütziger und privater Trägerschaft beteiligt sich die Deutsche Krankenhausgesellschaft (DKG) bereits seit vielen Jahren konstruktiv an den gesundheitspolitischen Diskussionen auf EU-Ebene. Die von der Europäischen…

EIGA urges simpler rules for medical gas devices

European Industrial Gases Association AISBL, 30 Sept 2025

EIGA requests uniform classification for medical devices to ensure regulatory consistency across Europe. They also advocate for lowering risk classifications for well-established gas distribution systems.
This would lower disproportionately high certification costs and minimize the operational impact on companies.
Notified Bodies would lose revenue by performing fewer audits on medical gas suppliers.

Consultation response

Biomedical Alliance in Europe, 6 Oct 2025

--Please find our response to the call for evidence attached-- SUMMARY: The BioMed Alliance supports the objectives of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to safeguard patient safety and ensure innovation. However, implementation has revealed significant…

Consultation response

SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V., 6 Oct 2025

SPECTARIS begrüßt die Initiative der Europäischen Kommission zur gezielten Revision der Verordnungen (EU) 2017/745 (MDR) und (EU) 2017/746 (IVDR). Die medizintechnische Industrie in Deutschland steht für Innovation, Qualität und Versorgungssicherheit. Die aktuellen regulatorischen Rahmenbedingungen…

Austrian Social Insurance warns against weakening medical device safety rules

Dachverband der österreichischen Sozialversicherung, 6 Oct 2025

The organization demands long-term clinical evidence instead of expected benefits to ensure patient safety. They oppose faster certification processes that rely on immature evidence and call for transparency regarding product withdrawals.
Strict evidence rules protect the healthcare system from funding treatments with unproven clinical benefits.
Medical device manufacturers may face higher costs and delays due to stricter data requirements.

Consultation response

Association Mieux Prescrire, 6 Oct 2025

Veuillez trouver ci-joint la contribution de Prescrire à l'appel à contributions concernant la révision ciblée des règles de l'UE relatives aux dispositifs médicaux et aux diagnostics in vitro.

Consultation response

Cepheid Europe SAS, 5 Oct 2025

The principles of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) are welcome, however implementation has fallen short in achieving its aims of a robust, transparent, predictable and sustainable regulatory framework for devices that ensures high levels of safety and…

Consultation response

Breakthrough T1D, 2 Oct 2025

Breakthrough T1D (formerly JDRF) appreciates the opportunity to provide comments on the targeted evaluation by the Commission on the EU rules for medical devices and in vitro diagnostics. ABOUT BREAKTHROUGH T1D As the leading global type 1 diabetes (T1D) research and advocacy organization,…

Consultation response

Rijksuniversiteit Groningen, 6 Oct 2025

The University of Groningen (RUG) is an innovative research university that includes the University Medical Center Groningen (UMCG), a large teaching hospital and research center for medicine, patient care, education, and innovative research, particularly focused on Healthy Ageing. We strongly…

Consultation response

The European Association of Medical Devices – Notified Bodies, 6 Oct 2025

Notified bodies (Team-NB and non-Team-NB members)

Consultation response

Hollandbio, 6 Oct 2025

Diagnostiek als sleutel tot gezondheid op maat Wanneer je ziek bent, wil je maar één ding: beter worden. Liever nog, blijf je gezond. De juiste behandeling op het juiste moment voor de juiste patiënt komt steeds dichterbij, dankzij vooruitgang op het vlak van diagnostiek en behandelingen. Alleen…

European Safety Federation Urges Simplified Rules for Medical PPE

European Safety Federation, 6 Oct 2025

The federation calls for proportionate rules for products like surgical masks and gloves. They argue that current clinical evaluation obligations for these items are disproportionate. They also seek alignment between medical device and protective equipment digitisation rules.
Reducing clinical testing for basic products would significantly lower business compliance costs.

Consultation response

Mölnlycke Health Care AB, 6 Oct 2025

Mölnlycke is eager to share insights based on its MDR early-adopter experience to inform the forthcoming revision of the Regulation. While the current Medical Device Regulation (EU) 2017/745 is a significant step towards creating uniform legislation for all actors in the medical device sector,…

Consultation response

Global Heart Hub, 6 Oct 2025

Global Heart Hub, the international alliance of cardiovascular patient organisations, supports the Commission's initiative to revise the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to reduce administrative burdens and enhance efficiency. However, we emphasize that…

Consultation response

Università Commerciale Luigi Bocconi, 6 Oct 2025

The IHI project HEU-EFS aims to establish a harmonised approach to Early Feasibility Studies (EFS) for medical devices in the European Union. ISO 14155:2020 defines EFS as limited clinical investigations which aim to evaluate the initial clinical safety and performance of a device. Conducted at an…

Consultation response

Industrie- und Handelskammer für München und Oberbayern, 6 Oct 2025

Der Industrie- und Handelskammer für München und Oberbayern vertritt die Interessen von rund 1.000 vor allem mittelgroße Betriebe mit 80.000 Beschäftigten in der bayerischen Medizintechnikbranche. Wir begrüßen das Bestreben der Europäischen Kommission, den Rechtsrahmen für Medizinprodukte (MDR) und…

Consultation response

Syndicat national de l'industrie des technologies médicales, 6 Oct 2025

Le Syndicat national de lindustrie des technologies médicales (Snitem) rassemble en France les acteurs de lindustrie des technologies et dispositifs médicaux y compris les entreprises impliquées dans le numérique en Santé. Il fédère 630 entreprises françaises ou internationales dont la plupart ont…

Consultation response

MedicalMountains GmbH, 6 Oct 2025

MedicalMountains GmbH welcomes the European Commissions initiative to launch an early evaluation and possible revision of the MDR. The system continues to show critical deficiencies, making this step both urgent and necessary. Immediate short-term solutions via delegated and implementing acts are…

Consultation response

GAIA AG, 11 Sept 2025

The current application of MDR Rule 11 leads to a systematic over-classification of Software as a Medical Device (SaMD). Even very low-risk applications, such as self-management or adherence apps, are routinely classified at least as Class IIa under a conservative interpretation. This contradicts…

Consultation response

Medical Device Manufacturers Association, 6 Oct 2025

Call for Evidence MDR / IVDR: Comments from MDMA (Medical Device Manufacturers Association) based in Washington DC with regulatory advisor in Brussels. MDMA welcomes the opportunity to submit evidence. The new regulatory framework should address the problems with the current system, which…

Consultation response

Medtech & Pharma Platform Association, 6 Oct 2025

The Medtech & Pharma Platform Association (MPP) wishes to respectfully draw attention to a series of persistent challenges that continue to hinder the effective and proportionate functioning of the European Unions regulatory framework governing medical devices and in vitro diagnostics. Foremost…

Consultation response

Verband der Diagnostica-Industrie, 6 Oct 2025

Der Verband der Diagnostica-Industrie e. V. (VDGH) begrüßt das Vorhaben der Europäischen Kommission, den Rechtsrahmen für In-vitro-Diagnostika grundlegend zu modernisieren und eine bessere Balance zwischen regulatorischer Sicherheit und wirtschaftlicher Machbarkeit zu schaffen. Verfahren sollten…

Consultation response

Laboratory Corporation of America Holdings, 6 Oct 2025

Labcorp is a global leader in innovative laboratory services and the market leader in central laboratory (CL) testing services. We have a strong R&D footprint in Europe, and our CL in Switzerland analyses samples from clinical trial patients in EMEA. A CL is a laboratory where specimen samples from…

Consultation response

Notified Body Coordination Group - Medical Devices, 6 Oct 2025

NBCG-Med Summary for EU COM Survey Submission NBCG-Med fully supports the objectives of the EU MDR and IVDR regulations to establish a robust, transparent, and sustainable framework that ensures high safety standards while fostering innovation. However, based on extensive data collection among…

Consultation response

KARL STORZ SE Co. KG, 6 Oct 2025

Critical areas requiring urgent action in the upcoming targeted revision of the MDR include: 0. Harmonization of definitions across MDR and accompanying legal documents. 1. Proportionate Recertification and QMS Audits Manufacturers call for a shift from full re-assessments to change-based reviews…

Consultation response

Council of European Dentists, 26 Sept 2025

The Council of European Dentists (CED) welcomes the Commissions envisioned review of the rules for medical devices. We fully share the goal of ensuring patient safety while supporting innovation and competitiveness. But in practice, the way the Medical Devices Regulation (MDR) is being implemented…

Consultation response

Association of Medical Device Reprocessors, 18 Sept 2025

The Association of Medical Device Reprocessors, AMDR, respectfully submits feedback with regard to Article 17, or the single-use device reprocessing provisions. Consistent with this call for evidences objectives, we strongly urge the Commission to recommend a simplification of Article 17.1 to…

Consultation response

Virtual Physiological Human Institute, 6 Oct 2025

Subject: Leveraging computer modelling and simulation methodologies including AI, to mitigate current challenges and prepare for future needs. The VPH Institute (VPHi), an international scientific society representing experts in in silico medicine (use of computer modelling and simulation in health…

Consultation response

Dedalus S.p.A., 6 Oct 2025

Dedalus is a well-established European-based medical software manufacturer regulated under MDR and IVDR. Our portfolio spans primary care, hospital systems, diagnostics, emergency care, and population health management. A significant share of our product range consists of clinical information…

Consultation response

Fédération européenne et internationale des Patrons Prothésistes dentaires, 6 Oct 2025

F.E.P.P.D.Submissions RE: Call for Evidence MDR. Please find in enclosed attachment.

Consultation response

EUROMCONTACT, 6 Oct 2025

EuromContact, representing manufacturers of contact lenses and lens care products, welcomes the targeted revision of the MDR and its objectives to streamline and future-proof the regulatory framework by reducing the administrative burden and enhancing predictability and cost-efficiency, while…

Consultation response

Medac Gesellschaft für klinische Spezialpräparate m.b.H., 6 Oct 2025

medac ist ein in Deutschland ansässiges Pharmaunternehmen mit Arzneimitteln gegen Krebs- und Autoimmunerkrankungen, das aber zusätzlich auch eine Medizintechnik- und Diagnostiksparte unterhält. medac begrüßt daher das Bestreben der Europäischen Kommission, den Rechtsrahmen durch eine Verringerung…

Consultation response

KCI Medical Belgium BV, 6 Oct 2025

Solventum welcomes the opportunity to submit this input, in response to the European Commissions public consultation on the targeted revision of EU rules for medical devices and in vitro diagnostics. Implementation complexity of the Medical Devices Regulation (MDR), inconsistent interpretations by…

Consultation response

British Dental Industry Association, 6 Oct 2025

The British Dental Industry Association welcomes efforts to address the systemic challenges facing the regulation of medical devices under the EU MDR. We believe that a targeted legislative intervention, coupled with appropriate ongoing support and oversight, can support patient outcomes through…

Consultation response

European Federation of High-tech Industries, 6 Oct 2025

EUROM welcomes the opportunity to provide feedback on the targeted revision of the EU rules for medical devices (MDR) and in vitro diagnostics (IVDR). This revision should aim to reduce bureaucratic burdens, strengthen governance and accountability, lower costs, foster competition and innovation,…

Consultation response

European Federation of Allergy and Airways Diseases Patients' Associations, 6 Oct 2025

The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of over 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We connect European stakeholders to ignite change and bridge the policy gaps on…

Consultation response

EURAMET e.V., 6 Oct 2025

Metrology, the science of measurement, plays a crucial role in developing and improving methods of quality assurance and standardization. It provides a means to achieve comparability of measurement results across different analytical systems, between laboratories, and across patient populations.…

Consultation response

Advanced Medical Technology Assoc., 4 Oct 2025

Overall: AdvaMed believes that the current issues in MDR/IVDR implementation are best addressed through application of both short-term measures, to be implemented as soon as possible, ideally this year, in combination with longer-term measures, as outlined in these two papers:…

Consultation response

Bundesverband Medizintechnologie, 4 Oct 2025

Der Bundesverband Medizintechnologie e.V. (BVMed) begrüßt vollumfänglich das Bestreben der Europäischen Kommission, den Rechtsrahmen durch eine Verringerung des Verwaltungsaufwands und eine Steigerung der Berechenbarkeit und Kosteneffizienz bei gleichzeitiger Wahrung eines hohen Maßes an…

Consultation response

Les Chirurgiens-Dentistes de France, 3 Oct 2025

Examen des règles européennes sur les dispositifs médicaux et recommandations du premier syndicat français de chirurgiens-dentistes (Les Chirurgiens-dentistes de France) Les CDF - Les Chirurgiens-dentistes de France - premier syndicat français saluent la révision annoncée par la Commission,…

Consultation response

European Federation of Clinical Chemistry and Laboratory Medicine, 3 Oct 2025

Feedback on the current IVDR and proposal for change on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) by their Committee European Regulatory Affairs chaired by Prof. Dr. Christa Cobbaert of its Division of Quality, Standards and Regulations, chaired by Prod.…

Consultation response

PHOENIX Pharma SE, 2 Oct 2025

To whom this may concern, PHOENIX group welcomes the commitment of the European Commission to revise EU rules on medical devices and in vitro diagnostics. We especially welcome the focus of the targeted revision on protecting patient health whilst making the medical device sector more agile in a…

Consultation response

Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, 2 Oct 2025

See uploaded file

Consultation response

HEATED COMMUNITY HUB, 1 Oct 2025

Heated Community Hub (HCH), a non-profit association committed to promoting public health and tobacco harm reduction, welcomes the European Commissions initiative to carry out a targeted revision of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). We believe this revision represents a crucial…

Consultation response

European Hearing Instrument Manufacturers Association, 26 Sept 2025

As set out in our earlier submission, the European Hearing Instrument Manufacturers Association (EHIMA) welcomes the opportunity to contribute to the European Commissions stakeholder consultation on the revision of the Medical Device Regulation (MDR). EHIMA urges the European Commission to revise…

Consultation response

Sensotrend Oy, 22 Sept 2025

Please find detailed feedback in the attached document.

Consultation response

Stiftung für Qualität und Wirtschaftlichkeit im Gesundheitswesen, 17 Sept 2025

Please find attached the feedback from the Institute for Quality and Efficiency in Health Care (IQWiG).

Consultation response

Europeans for Safe Connections, 16 Sept 2025

Europeans for Safe Connections (ESC) fully concurs with the stated objective of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which is "to establish a robust, transparent, predictable and sustainable regulatory…